Medical device firm Tem Systems aims to speed up blood analysis during surgeries and trauma situations.
Tem Systems has received U.S. Food and Drug Administration 510(k) clearance on new tests for its hemostasis analyzer and now the company aims to offer the technology to a wider group of users in the United States. Tem Systems, based in Durham, North Carolina, has developed an analyzer called ROTEM that can test for what is causing bleeding in a patient. That analysis comes in five to 10 minutes — much faster than traditional laboratory coagulation tests that can take 30 minutes.
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Tem Systems President Ken West said that ROTEM will supplement rather than replace existing lab tests. It will be used in circumstances when clinicians need speedy analysis of the blood.
“The real value is for trauma cases and open-heart cases,” West said.
ROTEM competes against a hemostasis analyzer developed by Massachusetts company Haemonetics (NYSE:HAE), which has already established a position for its analyzer in the U.S. hospitals market. Haemonetics reported $677 million in fiscal 2011 revenue; $19 million coming from diagnostics products, comprised mostly of its Thromboelastograph Hemostasis Analyzer products. The diagnostics revenue figure is a 15.8 percent increase over fiscal 2010 diagnostics revenue. In its annual report, Haemonetics attributes the increase to “new adoption of the product, particularly in the United States.” Haemonetics’s TEG analyzer competes against ROTEM in both Europe and the United States.
While Haemonetics’s device gathers all of its analysis from one test, Tem Systems’s West said that with the FDA clearance, Tem can now conduct five individual assays that can offer a more detailed analysis of the blood. West said ROTEM’s analysis is also five to 10 minutes faster than Haemonetics’s device, offering a time advantage over both lab tests and Haemonetics’s technology.
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Tem Systems is the U.S. subsidiary of Munich, Germany company Tem Innovations, which developed the ROTEM hemostasis analyzer. Tem Innovations first introduced its analyzer in Europe in 2003 and the company says the device is now used worldwide in more than 50 countries. ROTEM first received FDA clearance last year. West said that with the recent FDA clearance, Tem can now offer ROTEM to U.S. hospitals, blood banks and research centers.
Tem Systems currently has no R&D operations in the United States. The company’s parent has other bleeding management and hemostasis technologies in its medical device pipeline. That work is being conducted in Germany.
Tem Innovations explains its technology in this company video:
